US8753372B2 - Anchoring device and its implementation - Google Patents

Anchoring device and its implementation Download PDF

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Publication number
US8753372B2
US8753372B2 US10/524,701 US52470105A US8753372B2 US 8753372 B2 US8753372 B2 US 8753372B2 US 52470105 A US52470105 A US 52470105A US 8753372 B2 US8753372 B2 US 8753372B2
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Prior art keywords
locking element
aperture
anchor
space
tissue anchor
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US10/524,701
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US20050256530A1 (en
Inventor
Peter Emmanuel PETROS
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Pamarope Pty Ltd
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KVINNO CENTRE Pty Ltd
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Priority claimed from AU2002951024A external-priority patent/AU2002951024A0/en
Priority claimed from AU2002952128A external-priority patent/AU2002952128A0/en
Priority claimed from AU2003902559A external-priority patent/AU2003902559A0/en
Application filed by KVINNO CENTRE Pty Ltd filed Critical KVINNO CENTRE Pty Ltd
Assigned to KVINNO CENTRE PTY LTD. reassignment KVINNO CENTRE PTY LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PETROS, PETER EMMANUEL
Publication of US20050256530A1 publication Critical patent/US20050256530A1/en
Priority to US13/362,462 priority Critical patent/US10426594B2/en
Publication of US8753372B2 publication Critical patent/US8753372B2/en
Application granted granted Critical
Priority to US16/561,863 priority patent/US20200146809A1/en
Priority to US16/784,603 priority patent/US10925715B2/en
Assigned to Pamarope Pty Limited reassignment Pamarope Pty Limited ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KVINNO CENTRE PTY LTD.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0805—Implements for inserting tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0412—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from suture anchor body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • A61B2017/0437—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being resilient or spring-like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/0852—Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0876—Position of anchor in respect to the bone
    • A61F2002/0888—Anchor in or on a blind hole or on the bone surface without formation of a tunnel

Definitions

  • This invention relates to an anchor which can be used in surgical procedures on both humans and animals.
  • the invention has application to a wide variety of surgical procedures and one such procedure relates to a method of resolving female incontinence, which involves insertion of a filament which is to be fixed to the ligamentous tissue to either side of the vagina in order to reconstitute the ligamentary support for the urethra and/or vaginal wall.
  • a filament which is to be fixed to the ligamentous tissue to either side of the vagina in order to reconstitute the ligamentary support for the urethra and/or vaginal wall.
  • filaments have either been fixed to the pubic bone or alternatively the rectus abdominous muscle or left “tension free” in that muscle.
  • the invention resides in a method of providing ligamentory like support between two spaced locations in the body of a patient wherein the locations comprise ligament and/or muscle tissue comprising fixing an anchor in each location, connecting the anchors by a filamentary element, adjusting the tension of the filamentary element between the locations to establish the desired spatial relationship between the locations to provide at least a supplementary ligamentory support between the locations.
  • the anchors are provided with a retaining means adapted to be able to retain the filamentary element in optimal tension between the anchors.
  • the filamentary element is not biodegradable over a period of time and is adapted to facilitate the growth of tissue between the locations to provide said ligamentory support between the locations.
  • the head has a barbed configuration.
  • the barbed configuration comprises a set of prongs extending in a divergent manner from the end of the head towards the base, said prongs being resiliently flexible along their length, said method comprising compressing the ends of the prongs towards each other prior to insertion of the head into the tissue, inserting the head into the tissue and releasing the ends of the prongs once the head is located in the tissue.
  • the anchor is associated with a holder which is configured to retain the anchor with the head directed outwardly from the holder, the method comprising installing an anchor in the holder and placing the anchor in position in the tissue by means of the holder, subsequently disengaging the holder from the anchor.
  • the filamentary element is installed in the anchor and the anchor is installed on the holder prior to insertion of the head into the tissue.
  • the holder is adapted to receive and support the prongs in their compressed state, said method comprising releasing the prongs from engagement with the holder when the anchor is in position.
  • the holder is associated with an insertion appliance, the insertion appliance having a shaft, one end of the shaft adapted to receive the holder, the other end of the shaft supporting the handle, an ejection means extending between the handle and the one end and having a bearing member at one end adapted to bear upon an anchor when installed in the holder, the handle provided with a manipulation member adapted to cause the bearing member to bear on the anchor and cause the displacement of the anchor from the holder, said method comprising locating the holder at the one end of the shaft, installing an anchor into the holder, placing the anchor in position in the tissue by manipulation of the appliance and on location of the anchor in the tissue, activation of the manipulation means to cause displacement of the anchor from the holder.
  • the spaced locations comprise the recto-vaginal ligaments or the arcus tendineus ligaments to each side of the vagina and the method resides in the re-establishing of the fascial support for the vagina, said method comprising fixing said anchors into the recto-vaginal ligaments or the arcus tendineus ligaments respectively to each side of the vagina, applying the filamentary element between the anchors and introducing the filamentary element into the fascial tissue such that with time it will become embodied with the fascia and optimally tensioning the filamentary element between the anchors.
  • the filamentary element is applied to at least one of the anchors prior to fixation. According to a preferred embodiment of the invention the filamentary element is applied to a pair of anchors at a spacing greater than that desired spatial relationship.
  • the invention resides in a tissue anchor formed of a material which is compatible for location in human and/or animal muscle and/or ligament tissue, the anchor comprising a base and a head, the head having a configuration to facilitate insertion of the head into tissue and retention of the head in the tissue once inserted, the base formed with an aperture adapted to receive a length of a filamentary element and permit slidable movement of the filamentary element through the aperture in one direction but to restrict movement of the filamentary element through the aperture in the opposite direction.
  • the aperture is associated with a locking element positioned to extend across the aperture to define a space between the locking element and an opposed edge of the aperture, said space being intended to receive the filamentary element, the locking member having one face proximate the one direction and another face proximate the opposite direction, the locking element intended to cooperate with the filamentary element when in position in the space to restrict the movement of the filamentary element in the opposite direction and to enable movement of the filamentary element in the one direction.
  • the edge of the locking element defining the space is formed to engage the surface of the filamentary element when filamentary element is moved in the opposite direction.
  • the edge is defined by a surface extending between the faces of the locking member, the surface being inclined away from the opposed edge of the aperture in the opposite direction.
  • the edge is formed with slots which extend from the face proximate the one direction to at least an intermediate position across the surface.
  • the face of the locking member proximate the one direction is formed as a recess inwardly of the edge.
  • the locking member is inclined with respect to the base.
  • the space has a configuration substantially corresponding to the cross section of the filamentary element.
  • the space has a configuration corresponding to the cross sectional configuration of the filamentary element when under longitudinal tension.
  • the space has a part annular configuration.
  • the opposed edge of the locking element which is remote from the head has a convex arcuate configuration.
  • the space is located substantially centrally across the central longitudinal axis of the anchor.
  • the head has a barbed configuration.
  • the barbed configuration of the head is defined by a set of prongs, said prongs being located in substantially equi-distant spacing around the central axis of the head, said prongs being divergent away from the end of the head in the direction of base.
  • the prongs are of a tapered configuration. According to a preferred feature of the invention the outer end of the prongs are pointed. According to a preferred feature of the invention the prongs are resiliently flexible along their length.
  • the invention resides in a holder adapted to support the anchor as described above comprising a socket configured to clampingly receive the base, the socket being configured to allow access to the aperture, the clamping engagement between the holder and the base being such that on relative movement between the holder and the anchor the anchor is able to be disengaged from the holder.
  • the base has a substantially laminar-like configuration comprising two opposed substantially parallel faces.
  • the socket comprises a pair of spaced elements which receive opposed sides of the base with the aperture between the spaced elements.
  • the socket is defined by a set of boss elements which are configured to receive the free ends of the prongs of the anchor when compressed radially with respect to the central axis of the anchor.
  • an insertion appliance comprising a shaft adapted to accommodate the holder as described above at one end, the other end of the shaft supporting a handle, an ejection means extending between the one end and the handle, a bearing member provided at the one end and a manipulation means provided adjacent the handle whereby on an anchor being installed in the holder and on activation of the manipulation means the bearing member will bear upon the anchor to move the anchor from engagement with the holder.
  • a holder of the form described above having an anchor of the form described above applied thereto are provided as a single element.
  • an insertion appliance of the form described above supporting a holder of the form described above having an anchor of the form described above applied thereto are provided as a single element.
  • FIG. 1 is a schematic view of the posterior vaginal wall repair according to the first embodiment.
  • FIG. 2 is an isometric view of an anchor according to the second embodiment
  • FIG. 3 is a sectional isometric view of the anchor of the second embodiment
  • FIG. 4 is a side elevation of an insertion tool intended for use with the anchor of the second embodiment
  • FIG. 5 is an enlarged isometric view of the end of the insertion tool supporting an anchor according to the second embodiment.
  • FIG. 6 is an isometric view of an anchor according to the third embodiment.
  • FIG. 7 is a sectional side elevation of an anchor according to the third embodiment.
  • FIG. 8 is a side elevation of an anchor according to the third embodiment.
  • FIG. 9 is a sectional elevation of an anchor according to the third embodiment illustrating engagement between the anchor and a filamentary element
  • FIG. 10 is an isometric view of an anchor according to the third embodiment engaged with a filamentary element
  • FIG. 11 is an isometric view of an anchor according to the third embodiment in engagement with a cradle like support and also illustrating the anchor out of engagement with the cradle like support;
  • FIG. 12 is a sectional side elevation of an insertion appliance according to the third embodiment.
  • FIG. 13 is an isometric view of anchor and a holder according to the third embodiment
  • FIG. 14 is an isometric view of anchor according to the fourth embodiment.
  • FIG. 15 is an end elevation and two side elevation of a cradle like support according to the fourth embodiment.
  • FIG. 16 are isometric views of the cradle like support according to the fourth embodiment.
  • FIG. 17 is a side elevation of an insertion appliance according to the fourth embodiment.
  • FIG. 18 is an illustration of a pair of holder like supports each accommodating an anchor which in turn is received on a filamentary element;
  • FIG. 19 is illustrative of the initial step involved in operation of the anchor for insertion
  • FIG. 20 is an illustrative view of the insertion appliance subsequent to release of the first anchor
  • FIG. 21 is a schematic view of an insertion applicant applied to the second anchor
  • the method according to the first embodiment comprises utilisation of an anchor of the form described below as the second and third embodiments.
  • the anchor provides a means of attaching a filament into muscle and/or ligamentary tissue.
  • the anchor has a head which is able to be embedded into the tissue whereby once it is so embedded the anchor is retained in position.
  • the anchor has an attachment means which is able to receive and support a filament whereby the filament can slide through the attachment means in one direction but is restrained from slidable movement in the opposite direction.
  • the procedure according to the first embodiment involves forming a longitudinal incision in the anterior and/or posterior vaginal wall. This results in the creation of a pair of flaps 11 of fascial tissue to each side of the longitudinal incision. One or more lengths of filamentary element 13 are then fixed to each of either the recto-vaginal ligaments or the arcus tendineus (A.T.F.P.) ligaments which are located to each side of the vagina.
  • A.T.F.P. arcus tendineus
  • each length of filament is effected through a pair of anchors 15 of the form described below which receive the ends of the length of filament whereby because of the nature of the attachment means the spacing between the anchors 15 on the length of filamentary element 13 can be reduced by causing the filamentary element to be drawn through the attachment means of the anchor. The spacing between the anchors on the filamentary element cannot be increased.
  • the anchors 15 on each length of filamentary element 13 are embedded into the recto-vaginal ligaments in opposed relationship to each side of the vagina. Once the anchors 15 are attached, the nature of the attachment means of the anchors enables the length of the filament 13 between the ligaments to be reduced and to introduce a degree of tension into the filamentary element between the ligaments.
  • the flaps 11 of fascial tissue are then resutured into place. With the healing of the incisions the filamentary element becomes embodied into the fascial tissue on the anterior and posterior sides of the vaginal walls to provide reinforcement and support for that fascial tissue.
  • the tensioning of the filamentary element on its location in position between the recto-vaginal ligaments or the arcus tendineus (A.T.F.P.) ligaments enables the filamentary element to be precisely and sufficiently tightened to bring the fascia towards the mid-line and in so doing serves to repair any hernia. This serves to restore support for the vaginal wall and to facilitate the desired transmission of the muscle contraction to effect opening and closure of the urethra and anus without the muscle having initially to take up the laxity that previously existed in the connection between the fascial tissue and the recto-vaginal ligaments.
  • Each of the remaining embodiments are directed to an anchor which can be utilised in association with a filamentary element to enable the fixing and location of the filamentary element into a patient as described above in relation to the first embodiment.
  • the anchor 15 is shown at FIGS. 2 to 5 .
  • the anchor is formed integrally of a suitable plastics material which may be biodegradable and comprises a base 53 , a stem 55 which extends from the base 53 and a head 57 which is supported in spaced relation from the base 53 by the stem 55 .
  • the base is of a generally laminar configuration wherein the major faces of the base are substantially planar and parallel to the central axis of the stem 55 .
  • the base is formed with an aperture 61 which extends between the faces and which is associated with a locking member 63 which extends from the side of the aperture proximate the head 57 to terminate closely adjacent the other side of the aperture.
  • the free end of the locking member has a convex arcuate configuration to cooperate with the other side of the aperture to define a part annular space.
  • the spacing between the other side of the aperture and the free end of locking member approximately corresponds with the thickness of the filamentary element with which the anchor is to be used, when the filamentary element is tensioned.
  • the junction of the locking member with the one side of the aperture is such that the locking member can flex laterally out of the plane of aperture in one direction but is resistant to movement out of the plane aperture in the other direction.
  • This selective flexing of the locking member is achieved by forming the one face of the locking member 63 which faces the one direction with a recess 65 which has a boundary adjacent the junction.
  • the edge of the locking member 63 in the region adjacent the space is formed with a set of spaced slots 67 which extend from the one face partially across the end face of the locking member and which define a set of teeth at that edge.
  • the end face 69 of the locking member is divergent away from the other face of the aperture in the opposite direction.
  • the function of the selective flexing of the locking member 63 and the configuration of the teeth is to permit the filamentary element to be able to be pulled through the space between the locking member and the one side of the aperture in the one direction and to prevent movement of the filamentary element through the same space in the opposite direction.
  • the engagement of the filamentary element by the locking member when the filamentary element is moving in the opposite direction is enhanced by the part annular configuration of the space through which the filamentary material is required to pass which causes the filamentary element to furrow in its passage through the space and thus engage with the free edge of the locking member.
  • the divergent nature of the end face 69 serves to guide and enable the movement of the filamentary element in the one direction.
  • the head 57 of the second embodiment comprises an outer portion 71 which has a pointed conical configuration.
  • the head 57 has a barbed configuration which is provided by a set of prongs 72 which extend rearwardly from the outer portion 71 in a divergent relationship to each other.
  • the arms 69 are spaced angularly equi-distant around the central axis of the stem 55 and each of the arms are of a generally tapered configuration with their outer ends being more convergent than the main portion of each prong 72 . Because of the nature of the plastics material of which the anchor is formed the prongs are capable of resilient flexing along their length and at their junction with the stem.
  • the anchor 15 of the second embodiment is intended to be attached to a length of the filamentary element (not shown) and the filamentary element is inserted into the body of a patient by utilisation of an insertion appliance 70 which is illustrated at FIGS. 4 and 5 .
  • the insertion appliance comprises a tubular body 73 which is provided at one end with a handle 75 and at the other end with a cradle-like support 77 .
  • the cradle-like support 77 is configured to receive the base of the anchor 15 of the second embodiment and support the anchor as shown at FIGS. 4 and 5 with the head 71 extending axially away from the end of the appliance.
  • the internal bore of the insertion tube slidably supports a pushrod 79 which extends from the one end of the tubular body and is provided with an enlarged head 81 at its outer end
  • the other end of the pushrod is received through a passageway through the cradle-like support 77 to terminate closely adjacent the anchor when supported in the cradle-like support 77 .
  • a suitable biasing means is provided between the tubular body 73 and the pushrod 79 to bias the pushrod to its outermost position with respect to the tubular body 73 .
  • the anchor 15 is located in the cradle-like support 77 of the insertion tube and the filamentary element (not shown) is initially passed through the aperture of the anchor.
  • the insertion tube 73 is then inserted into the body cavity through an opening in the body wall such that the free end of the insertion tube with the anchor located thereon is located against the surface of a layer of muscle tissue.
  • the anchor 15 With the application of an inward axial force on the enlarged head 81 of the pushrod 79 , the anchor 15 is caused pass into the muscular tissue to become lodged therein. Because of the pointed configuration of the outer portion 71 of the head, the anchor 15 will move readily into engagement with the tissue, however because of the divergent nature of the arms 25 , dislodgement of the anchor from the tissue is restricted.
  • the insertion appliance 70 can be removed from the body to leave the anchor and filamentary element 27 in place.
  • a second anchor is engaged with the filamentary element at its other end and the second anchor is then fixed to another location in a similar manner using the insertion appliance. Because the filamentary element is only capable of movement through the aperture of the anchors in one direction, the length of the filamentary element supported between the anchors can be reduced, to reduce the spacing between the locations and can be tensioned.
  • the tensioning applied to the filamentary element is such as to restore the normal tension which is expected at the at site to enable the muscular action which is available to be used to control the urethra.
  • the anchor 115 is shown at FIGS. 6 to 13 .
  • the anchor is formed integrally of a suitable plastics material which may be biodegradable and comprises a base 153 , a stem 155 which extends from the base 153 and a head 157 which is supported in spaced relation from the base 153 by the stem 155 (at a reduced spacing compared to the second embodiment).
  • the base is of a generally laminar configuration wherein the major faces of the base are substantially planar and parallel to the central axis of the stem 155 .
  • the base is formed with an aperture 161 which extends between the faces and which is associated with a locking member 163 which extends from the side of the aperture proximate the head 157 to terminate closely adjacent the other side of the aperture.
  • the locking member 163 is substantially planar and is inclined with respect to the central transverse plane of the base from one face to the other face.
  • the free edge of the locking member has a convex arcuate configuration to cooperate with the other side of the aperture to define a part annular space.
  • the spacing between the other side of the aperture and the free edge of locking member approximately corresponds with the thickness of the filamentary element with which the anchor is to be used when the filamentary element is tensioned.
  • the locking member is of a reduced thickness compared to the thickness of the base and as a result the locking member can flex within the aperture.
  • edge of the locking member 163 in the region adjacent the space is formed with a set of angularly spaced slots 167 which extend from the one face partially across the end face 169 of the locking member to define a set of teeth at that edge.
  • end face 169 of the locking member is divergent away from the other face of the aperture in the opposite direction.
  • the divergent nature of the end face 169 serves to guide and enable the movement of the filamentary element in the one direction.
  • the filamentary element 127 is moving in the one direction it is anticipated that it will be in a state of tension and as a result it is expected that the locking member will not interfere with the filamentary element 127 when it is moving in the one direction since the dimensions of the space will correspond with the cross section of the tensioned filamentary element 127 passing through it.
  • the flexing of the locking member 163 , the configuration of the teeth 167 and the configuration of the end face 169 also serve to, prevent movement of the filamentary element 127 through the same space in the opposite direction.
  • the engagement of the filamentary element 127 by the locking member when the filamentary element 127 is moving in the opposite direction is enhanced by the part annular configuration of the space through which the filamentary element 127 is required to pass which causes the filamentary element 127 to furrow in its passage through the space and thus engage with the free edge of the locking member as shown at FIGS. 9 and 10 .
  • the portion of the element approaching the aperture will generally not be in tension and this condition of the element together with the configuration of the space, serves to further enhance the interference that the locking member creates for movement of the filamentary element.
  • the head 157 of the third embodiment comprises an outer portion 171 which has a pointed conical configuration.
  • the head 157 has a barbed configuration which is provided by a set of prongs 172 which extend rearwardly from the outer portion 171 in a divergent relationship to each other.
  • the arms 169 are spaced angularly equidistant around the central axis of the stem 155 and each of the arms are of a generally tapered configuration with their outer ends being more convergent than the main portion of each prong 172 . Because of the nature of the plastics material of which the anchor is formed the prongs are capable of resilient flexing along their length and at their junction with the stem.
  • the anchor 115 of the third embodiment is intended to be attached to a length of the filamentary element as shown at FIGS. 9 and 10 and the filamentary element is inserted into the body of a patient by utilisation of an insertion appliance 170 which is illustrated at FIG. 12 .
  • the insertion appliance comprises a tubular body 173 which is provided at one end with a handle 175 and at the other end is adapted to receive a cradle-like support 177 .
  • the cradle-like support 177 is configured to receive the base of the anchor 115 of the third embodiment and support the anchor as shown at FIGS. 6 to 10 with the head 171 extending axially away from the end of the appliance.
  • the cradle-like support is described in greater detail below.
  • the internal bore of the insertion tube slidably supports a pushrod 179 which extends from the one end of the tubular body into the interior of the handle 175 .
  • the other end of the pushrod is received through a passageway through the cradle-like support 177 to terminate closely adjacent the anchor when supported in the cradle-like support 177 .
  • a suitable biasing means is provided between the tubular body 173 and the pushrod 179 to bias the pushrod towards the handle.
  • the handle slidably receives a rod-shaped plunger 183 and the outer end of the pushrod 179 bears on the plunger 18 .
  • the portion of the surface of the plunger which receives the pushrod is profiled with a notched portion 185 which receives the outer end of the pushrod when in its retracted position and with an increased diameter portion 187 which will receive the outer end of the pushrod when the plunger is pushed axially inwardly into the handle to cause the pushrod to move to its extended position.
  • the pushrod When the pushrod is at its extended position it will bear upon anchor 115 supported on the cradle-like support 177 to force the anchor out of engagement with the cradle-like support 177 .
  • the cradle-like support comprises a central spigot 187 which is intended to be received in the end of the tubular body 173 and is configured to be frictionally engaged in the end.
  • the outer end of the spigot supports cradle 189 which is shaped to support the base 153 of an anchor at the sides.
  • the cradle is recessed to provide free access to the aperture 161 .
  • the sides of the recess are configured at their outer ends to receive and support the free ends of the prongs 172 when compressed radially relative to each other as shown at FIG. 11 .
  • the cradle-like support is formed with a central passage which receives the pushrod 179 of the insertion appliance whereby when the pushrod is at its extended position it bears upon the base of the anchor to force it out of engagement with the cradle 189 .
  • the anchor is free of the cradle-like support the free ends of the prongs are able to expand radially.
  • a holder 191 of the form shown at FIG. 13 is used.
  • the holder comprises body having a grip 193 at one end and an anchor support 195 at the other end.
  • the grip 193 comprises a pair of opposed tabs 197 which are dimensioned and spaced from each other to be able to be engaged between a finger and thumb of the operator.
  • the anchor support comprises a cross-like recess 199 which is configured to receive the head of the anchor, including the prongs and in so doing to radially compress the free ends of the prongs in order that they can be received in the cradle 189 of the cradle-like support.
  • the head of an anchor 115 is located in the recess of the holder and is then transferred to the cradle-like support 177 to be supported therein. This location and transfer of the anchor can be effected using the holder and without manually handling the anchor.
  • the anchor preloaded with the filamentary element is supported in the cradle-like support.
  • the insertion tube 173 is then inserted into the body cavity of the patient through an opening in the body wall such that the free end of the insertion tube with the anchor located thereon is located against the surface of a layer of muscle tissue. On application of additional force the head of the anchor as well as a portion of the cradle-like support is introduced into the muscle tissue.
  • the pushrod 179 forces the anchor out of engagement with the cradle-like support to be received in the muscle tissue and to become lodged therein.
  • the radial expansion of the free ends of the prongs when free of the cradle further serve to ensure retention of the anchor in the tissue.
  • the anchor 115 Because of the pointed configuration of the outer portion 171 of the head, the anchor 115 will move readily into engagement with the tissue, however because of the divergent nature of the prongs 125 , dislodgement of the anchor from the tissue is restricted.
  • the retention of the free ends of the prongs in the cradle enables the operator some degree of freedom in locating the anchor and the prongs are only released when the operator is satisfied with the location of the anchor.
  • the insertion appliance 171 can be removed from the body to leave the anchor and filamentary element 127 in place.
  • a second anchor at the other end of the filamentary element is then fixed to another location in a similar manner using the insertion appliance. Because the filamentary element is only capable of movement through the aperture of the anchors in one direction, the length of the filamentary element supported between the anchors can be reduced, to reduce the spacing between the locations and can be tensioned.
  • the tensioning applied to the filamentary element is such as to restore the normal tension which is expected at the at site enable the muscular action which is available to be used to control the urethra.
  • an anchor 215 of the form as shown at FIG. 14 and which generally corresponds with an anchor according to the third embodiment is applied to a cradle-like support 277 .
  • the cradle-like support 277 is formed as a tubular element which is receivable over the outer end of insertion tool 270 and is formed at one end with a cradle like portion which will support and engage the anchor 215 in a similar manner to that described in relation to the third embodiment and as shown in the accompanying drawings.
  • the configuration of the insertion appliance 270 is of the same form as that of the third embodiment.
  • the tubular portion of the cradle-like support is formed towards its other end to be of a bifurcated configuration to allow for resilient flexing between the bifurcated portions of the tubular portion so defined when other end of the cradle-like support is applied over the outer end of the insertion appliance in order that they clampingly engage the outer surface of the tubular portion at 273 of the insertion appliance 270 .
  • suitable detents may be provided in the wall of the tubular portion 273 to retain the cradle-like support in position on the end of the insertion appliance.
  • the insertion appliance 270 is provided with a collar 292 which is slidable on the tubular portion of the insertion appliance 270 .
  • the collar 292 is provided with a pair of diametrically opposed prongs 294 which will engage in the slots between the bifurcations of the cradle-like support and with appropriate axial movement of the collar on the tubular member will cause separation between the bifurcations to facilitate removal of the cradle-like support from engagement with the insertion appliance.
  • the cradle-like support 277 and the anchor 215 is provided as a single item and it is intended that a pair of composite items be provided on a length of filamentary element 227 as a pre-packaged composite item whereby the anchors 215 are sequentially installed using an insertion tool in a manner as illustrated at FIGS. 20-21 .
  • the anchors are used to directly shorten a stretched ligament or fascial tissue by inserting a pair of anchors into a ligament at spaced intervals along the ligament and shortening the ligament or fascial tissue by tensioning the filamentary element between the anchors.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Rheumatology (AREA)
  • Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Rehabilitation Therapy (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)
US10/524,701 2002-08-13 2003-08-15 Anchoring device and its implementation Active 2026-08-05 US8753372B2 (en)

Priority Applications (3)

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US13/362,462 US10426594B2 (en) 2002-08-13 2012-01-31 Anchoring device and its implementation
US16/561,863 US20200146809A1 (en) 2002-08-23 2019-09-05 Anchoring device and its implementation
US16/784,603 US10925715B2 (en) 2002-08-23 2020-02-07 Anchoring device and its implementation

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
AU2002951024 2002-08-13
AU2002951024A AU2002951024A0 (en) 2002-08-23 2002-08-23 Anchor and application thereof
AU2002952128 2002-10-17
AU2002952128A AU2002952128A0 (en) 2002-10-17 2002-10-17 Surgical method
AU2003902559 2003-05-23
AU2003902559A AU2003902559A0 (en) 2003-05-23 2003-05-23 Anchoring device and its implementation
PCT/AU2003/001036 WO2004017845A1 (fr) 2002-08-23 2003-08-15 Dispositif d'ancrage et sa mise en oeuvre

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US20050256530A1 US20050256530A1 (en) 2005-11-17
US8753372B2 true US8753372B2 (en) 2014-06-17

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US13/362,462 Expired - Fee Related US10426594B2 (en) 2002-08-13 2012-01-31 Anchoring device and its implementation
US16/561,863 Abandoned US20200146809A1 (en) 2002-08-23 2019-09-05 Anchoring device and its implementation
US16/784,603 Expired - Fee Related US10925715B2 (en) 2002-08-23 2020-02-07 Anchoring device and its implementation

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US16/561,863 Abandoned US20200146809A1 (en) 2002-08-23 2019-09-05 Anchoring device and its implementation
US16/784,603 Expired - Fee Related US10925715B2 (en) 2002-08-23 2020-02-07 Anchoring device and its implementation

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US (4) US8753372B2 (fr)
EP (1) EP1545351B1 (fr)
JP (1) JP4875362B2 (fr)
KR (1) KR101013653B1 (fr)
CN (1) CN100479768C (fr)
AT (1) ATE552788T1 (fr)
AU (1) AU2003250591B2 (fr)
BR (1) BRPI0313292B1 (fr)
CA (1) CA2495105C (fr)
EA (1) EA007116B1 (fr)
ES (1) ES2385825T3 (fr)
IL (1) IL166942A (fr)
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US10426594B2 (en) 2019-10-01
KR20050038627A (ko) 2005-04-27
AU2003250591B2 (en) 2007-06-21
AU2003250591A1 (en) 2004-03-11
KR101013653B1 (ko) 2011-02-10
WO2004017845A1 (fr) 2004-03-04
EP1545351A4 (fr) 2006-07-26
US20200146809A1 (en) 2020-05-14
CN1678247A (zh) 2005-10-05
JP2005536316A (ja) 2005-12-02
JP4875362B2 (ja) 2012-02-15
IL166942A (en) 2008-12-29
CN100479768C (zh) 2009-04-22
EP1545351A1 (fr) 2005-06-29
ES2385825T3 (es) 2012-08-01
US20200170781A1 (en) 2020-06-04
US10925715B2 (en) 2021-02-23
NZ538131A (en) 2006-12-22
BRPI0313292B1 (pt) 2015-03-17
EA200500160A1 (ru) 2006-02-24
US20050256530A1 (en) 2005-11-17
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ATE552788T1 (de) 2012-04-15
BR0313292A (pt) 2005-07-05

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